Project Resourcing Solutions

We partner with your team to identify how to build, support and manage the expertise that is critical to your projects and operations.

This can be as simple as the provision of a single resource, or as comprehensive as a full scale program management solution – developing schedules, integrating cross-functional expertise, monitoring and maintaining program health.

 

Quality

Pre-market Quality Engineering - iconPre-market Quality Engineering

  • Design Controls
  • Inspection Methods
  • EN ISO 14971:2012 Risk Management
  • Supplier Qualification
  • Process Validation

Quality System Management - icon Quality System Management

  • Internal Audits
  • MDSAP Preparation and Maintenance
  • CAPA Management
  • Design, Development, Install and / or Remediation of QMS
  • Specific Emphasis within 21 CFR Part 820, ISO 13485:2016

Post-market Quality EngineeringPost-market Quality Engineering

  • Ongoing Supplier Management
  • Complaint Triage / Investigation and Root Cause Analysis
  • Medical Device Reporting (MDRs)
  • MRB & NCR management

CQV - IA / OQCQV

  • Commissioning & Qualification (IQ / OQ)
  • Validation (PQ)
  • Plan and Protocol Generation and Execution
  • Program Assessments

 

Regulatory & Compliance

Remediation Efforts - iconRemediation Efforts

  • Audit Findings
  • 483’s & Warning Letters
  • Consent Decree
  • Mock Audits

Product Specific Compliance - iconProduct Specific Compliance

  • EU MDR Compliance Deliverables
  • UDI Compliance / GUDID Submissions (US)
  • Standards Compliance
  • Marketing Material Review

General Compliance - iconGeneral Compliance Activities

  • Facility Registration / Device Listing Guidance
  • EU MDR Compliance Strategy
  • Inspection Readiness (Pre and Post Approval)

Submissions - iconSubmissions

  • Submission Strategy
  • Technical Document Preparation – IDE, 501(k), PMA, IND
  • Hazardous Substances Review
  • Labeling Review
  • Quality System Update Support

Single Resource - Completely Managed